510(k) · Cleared
ClearedPermanent Sled Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Sep 22, 2015 as substantially equivalent to K130243 (Boston Scientific Corp, 2013) after a 28-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Sep 22, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921750 (1992). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK921750 Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc. · 1992
- 5 generations backK980851 Galaxy Intravascular Ultrasound System, Model I5028Boston Scientific Corp · 1998
- 4 generations backK051679 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2005 · Recalled
- 3 generations backK072517 Ilab Ultrasound Imaging System, Version 1.3Boston Scientific Corp · 2007 · Recalled
- 2 generations backK123535 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2013
- 1 generation backK130243 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2013
- This deviceK152403 Permanent Sled BagBoston Scientific · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921750 | Cvis Insight Iii System | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −5 | K980851 | Galaxy Intravascular Ultrasound System, Model I5028 | Boston Scientific Corp | 1998 | — |
| −4 | K051679 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2005 | 2 |
| −3 | K072517 | Ilab Ultrasound Imaging System, Version 1.3 | Boston Scientific Corp | 2007 | 1 |
| −2 | K123535 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2013 | — |
| −1 | K130243 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2013 | — |
| 0 (this device) | K152403 | Permanent Sled Bag | Boston Scientific | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130243 | Ilab Ultrasound Imaging SystemSummary page 4…agnostic (accessory) 21 CFR Part 8§92.1570 (901TX) Radiology/Cardiology Panel Product Code: 90ITX Predicate Device: Product 510(k) Clearance Date MDUS PLUS Sterile Bag K130243 March 1, 2013 Boston Scientific Corporation Special 510(k) Permanent Sled Bag Page 86 of 90 Description of the… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 3 other devices also cite its predicate K130243.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The sterile bag is intended to cover the motordrive/sled assembly during intravascular ultrasound procedures to maintain the sterile field and prevent transfer of microorganisms, body fluids and particulate material to the patient and healthcare worker.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152403: Permanent Sled Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152403
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026